Q 4. What are the four layers of documents of ISO 9000? Please explain the purpose of each layer of document and their interelationship
ISO 9000 emphasis on document control as it could act as a means of communication, define and clarify quality activities, rationalize the work of quality assurance, facilitate quality control, provide a base for system audit, and as teaching materials.
While the above benefit bases on 4 types of documents, according to ISO9001: 2008, 4.2.1, the quality management system documentation shall include: 1. Quality Policy and Quality Objectives, Quality Manual
Quality Policy refer to the company’s position, developed by managerial and quality professionals to express the expectation, acceptance of quality, and dedicate each role with responsibilities to ensure quality.
Quality Manual is an official document recording company policy, goals and detailed description of company quality control system. In brief Quality manual is an documentation of Quality Policy and Object, which could be read , stored and shared within organization. 2. Companies Operation Procedures
This document mainly focuses on recording methods, roles of responsibilities for implementing quality system. Such as recording purchasing manger are responsible for certification on quantity received is the same on the invoice, and send correction action request (CAR). Such that, everything related to Quality procedure could be traced for investigation or improvement.
3. Work Instruction
Work instruction refer to technical specification of how to implement quality procedure in detail, step by step approach to draw out the quality system. It could be treated as quality-service blueprint, helping mangers to identified loophole and easy failure point.
4. Forms and Records.
This element help managers and companies to record parameter of production process, and quality indicator, such as in plastic injection process, humidity, temperature...
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